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U.S. Department of Health and Human Services

For Industry

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FDA Orphan Product Designation and Grant Workshop

The Office of Orphan Products Development (OOPD) is collaborating with our EMA colleagues in conducting a Joint EMA/FDA/PMDA Orphan Designation Workshop on Monday, March 10, 2014 at the EMA offices in London, England. 

For more information about this workshop and registration details, visit the EMA orphan workshop website disclaimer icon .

Future Plans

We are planning to reschedule the Orphan Designation and Grant workshop (initially planned for October 4, 2013), and will post information regarding the date, time and location as soon as we have it.

Workshop Description- This one-day workshop is designed to provide valuable information about the EMA and FDA Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as to academics. 

For questions about the FDA Orphan Product Designation and Grant Workshop, please contact: Eleanor Dixon-Terry at Eleanor.Dixon-Terry@fda.hhs.gov


The FDA/EMA Orphan Product Designation and Grant Workshop is conducted in partnership with the European Organisation for Rare Disease (EURORDIS), Genetic Alliance, and the National Organization for Rare Disorders (NORD).